A Multicenter, Open-Label, Dose Escalation Study of the Safety, Tolerability, and Efficacy of Budiodarone for the Treatment of Subjects with Non-permanent Atrial Fibrillation

Condition studied

Non-permanent Atrial Fibrillation

Investigational medicinal product(s)

Eligibility

Primary endpoint

Safety: • Incidence of TEAE and treatment-emergent serious adverse events (TESAE). • Incidence of AESI • Mortality and Clinical Morbidity Events: o Death o Resuscitated sudden cardiac death (SCD) including appropriate implanted cardiac defibrillator (ICD) discharge o Cardiovascular hospitalization o Stroke or another thromboembolic event • Physical Exam assessments and abnormalities. • Vital sign assessments and abnormalities. • Clinical laboratory assessment and abnormalities. o Thyroid functio, Primary Efficacy: • Proportion of participants that have no LEAF (uninterrupted episode of AF that is 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is greater than 5 hours) in the final month of treatment., Exploratory Endpoint: • The proportion of participants with no LEAF episodes lasting one hour or longer in the final month of budiodarone treatment

Endpoint detail

Secondary Efficacy: • Change in percent AFSS during final month of treatment compared to baseline for multiple doses of budiodarone. • PGI-C during the final month of treatment. • Percent change in AFB during final month of treatment compared to baseline.